Coated tracheostomy tube and stoma stent or cannula

ABSTRACT

The present invention relates to devices used in the management of bodily airways including tracheostomy tubes, laryngectomy tubes, bronchial stents, bronchial Y-tubes, bronchial TY-tubes, and nasal stents. The devices may comprise a protective coating to prevent the accumulation of mucus, crusting and granulation on or around airway management devices, as well as prevent adhesion to tissues which can cause bleeding upon removal, and prevent build-up of blood, or blood clots, to the stent.

INCORPORATION BY REFERENCE

This application is a continuation-in-part of, and claims priority to,U.S. patent application Ser. No. 11/440,905.

The foregoing application, and all documents cited therein or duringtheir prosecution (“application cited documents”) and all documentscited or referenced in the application cited documents, and alldocuments cited or referenced herein (“herein cited documents”), and alldocuments cited or referenced in herein cited documents, together withany manufacturer's instructions, descriptions, product specifications,and product sheets for any products mentioned herein or in any documentincorporated by reference herein, are hereby incorporated herein byreference, and may be employed in the practice of the invention.

FIELD OF THE INVENTION

The present invention relates to devices used in the management ofbodily airways including tracheostomy tubes, laryngectomy tubes,bronchial stents, bronchial Y-tubes, bronchial TY-tubes, and nasalstents. The devices may comprise a protective coating to prevent theaccumulation of mucus, crusting and granulation on or around airwaymanagement devices, as well as prevent adhesion to tissues which cancause bleeding upon removal, and prevent build-up of blood, or bloodclots, to the stent.

BACKGROUND OF THE INVENTION

A wide variety of airway management devices exist. Airway managementdevices may be used for a variety of reasons including the facilitationof speaking and breathing following a laryngectomy, the promotion ofhealing in the patient, the provision of an access point for forcedventilation of a patient, and a variety of other uses includingsupplying oxygen to augment normal breathing. In particular, attentionis directed to tracheostomy tubes and devices used in conjunction withairways, for example, stoma stents, tracheal T-tubes, transtrachealoxygen stents, bronchial stents, and nasal splints, among others.

Tracheostomy tubes are used to administer positive-pressure ventilation,to protect against aspiration, to provide an airway in patients prone toupper airway obstruction, and to provide access to the lower respiratorytract for airway clearance. Tracheostomy devices may be designed to beused with an inner cannula. The inner cannula is inserted into the tubeor outer cannula, and is used to maintain the airway provided by theouter cannula as clean. The inner cannula may be disposable or may bereusable such that it is cleaned or replaced periodically with a newinner cannula. The inner cannula can be a low-profile inner cannulawhich is used for spontaneous breathing, or an inner cannula with aconnector to attach a ventilator.

Stoma stents are prostheses that are held in place in the stomafollowing a tracheostomy to help maintain patency of the tracheostomy.Bronchial stents are prostheses that relieve an area of obstruction inthe airways that lead to each lung.

Those of skill in the art will appreciate that the management of bodilyairways is not limited to those devices enabling respiration, but rathermay extend to the panoply of devices relating to diseases of the larynx,pharynx, or nasal passages.

A laryngectomy is one procedure that implicates airway managementdevices. A patient may undergo a laryngectomy in response to cancer ofthe larynx or possibly because of trauma to the region. A totallaryngectomy will have profound effects on the patient. In a totallaryngectomy, the larynx is surgically separated from the mouth, noseand esophagus, and the entire larynx, including the vocal chords, isremoved. The patient must thereafter use a laryngectomy tube forbreathing. Further, due to the separation and lack of vocal chords, apatient may initially be unable to speak.

Some airway management devices are non-respiratory in the sense thatthey do not enable breathing directly, but still are related to therespiratory system generally. In healthy individuals, the larynx isinstrumental for speech, but for laryngectomicized individuals speech isstill possible through alternative methods using speech prostheticdevices. Voice button devices, such as a “Panje” voice button and a“Groningen” voice button, help restore speech by allowing air, but notfluids, through an artificial fistula formed between the larynx and theesophagus.

Other non-respiratory airway management devices include salivary bypasstubes and esophageal tubes. Laryngectomies may create salivary fistulaswhich are problematic if formed over the laryngectomy stoma. Thisdetrimental post-laryngectomy effect can be treated by using a salivarybypass tube. Also, following a laryngoesophagectomy, an esophageal tubemay be used to bridge the gap between the pharyngostome andesophagostome.

Another example of a condition that may necessitate an airway managementdevice is laryngeal stenosis. Laryngeal stenosis may occur if a patienthas been intubated for a prolonged period of time. One device used inits treatment is a laryngeal umbrella keel. Laryngeal umbrella keels aresometimes used before removing a laryngeal stent, to insure reformationof a sharp anterior commissure and to prevent formation of an anteriorweb.

Nasal splints are often used to relieve obstructions in the nasalcavity. Obstructions may occur, for example, following surgery of thenasal cavity and paranasal sinuses, which often results in the mucosallining the nasal cavity becoming raw and rough and to form scars. Theyare inserted after nasal surgery on turbinates, the polyps(polypectomy), the septum (septoplasty), and after sinus surgery. Thesplints offer an airway (if the design incorporates a lumen, or tube);reduce, prevent or treat, the occurrence of synechiae formation(granulation); prevent adhesions of tissues or membranes within thenasal cavity; and control bleeding.

However, all of these devices suffer from several drawbacks. Airwaymanagement devices are often plagued by granulation, crusting and mucusbuild up. Further, such devices run the risk of compromising bodilywalls and can be difficult for the patient to clean and maintain. Inaddition, ease of insertion and removal of complementary devices such astubes can be hampered by the build up or encrustation of bodily fluidsor by device fit friction. At the same time, however, another problemwith airway management devices is the possibility of becomingaccidentally dislodged. Thus there is a need for airway managementdevices which prevent build up of mucus, encrustation, or bodily fluids,yet remain firmly implanted in the patient with little likelihood ofbecoming accidentally dislodged. The present invention is directedtowards a device solving these and other problems associated with theknown devices.

SUMMARY OF THE INVENTION

One aspect of the present invention is directed to an airway managementdevice including a tube with a lumen extending therethrough and with thetube having an inner and outer surface. The outer surface and innersurface of the tube have a protective polymeric coating.

An aspect of the invention is directed to an inner cannula for use withan airway management device such as a tracheostomy tube. The innercannula may comprise an open distal end, an open proximal end thatextends, a lumen extending therebetween having an inner surface, and anouter surface. Between the distal and proximal ends, the inner cannulamay comprise a general curvature. In some embodiments, the inner cannulacomprises a protective coat that covers one or more portions of theouter surface and/or inner surface of the stent In certain embodiments,the coating is a polymeric coating, such as parylene.

Another aspect of the present invention is directed to a stoma stentsystem including a tube with a lumen extending therethrough, an exteriorflange formed on the proximal end of the tube, and a tracheal flangeformed on the distal end of the tube. The tube fluidly connects theexterior flange to the tracheal flange. The exterior flange and thetracheal flange have a protective polymeric coating.

A still further aspect of the present invention is directed to a voiceprosthesis device including a voice button with a lumen extendingtherethrough, a tracheal flange attached to a tracheal end of the voicebutton and an esophageal flange attached to the esophageal end of thevoice button. The inner surface of the voice button, the trachealflange, and the esophageal flange are coated with a protective polymericcoating.

Yet another aspect of the present invention relates to a bronchial stenthaving a generally tubular shape. In certain embodiments, the stent maycomprise an open distal end, an open proximal end, a lumen extendingtherebetween having an inner surface, an outer surface, and alongitudinal axis through the center of the lumen. In certainembodiments, the bronchial stent may comprise a means to preventmovement or displacement of the stent, and may further comprise aprotective coating that covers one or more portions of the outer surfaceor inner surface of the stent.

In certain embodiments, the means to prevent movement or displacement ofthe stent may be one or more rings around the circumference of thestent, or the like. These rings may be located on the distal end of thestent, on the proximal end of the stent, in the middle of the stent, orany combination thereof.

In other embodiments, the means to prevent movement or displacement ofthe stent may be one or more posts that extend outwardly from the outersurface of the stent, or the like. The posts may be cylindrical, cubic,pyramidal, or prism-shaped. Also, the posts may be distributed randomlyor in a pattern along the outer surface of the stent.

In certain embodiments, the means to prevent movement or displacementmay be both rings and posts.

The protective coating on the bronchial stent may be a polymericcoating. The polymer may be parylene.

In certain embodiments, the distal end of the bronchial stent bifurcatesinto a first tubular diagonal arm and a second tubular diagonal arm,wherein each arm comprises an open distal end, an open proximal end, alumen therebetween having an inner surface, an outer surface, and alongitudinal axis through the center of the lumen of each diagonal arm.In some embodiments, the lumen in the tubular diagonal arms iscontinuous with the lumen of the stent. In certain embodiments, thelengths of the first tubular diagonal arm and the second tubulardiagonal arm may be equal or unequal.

In further embodiments, the longitudinal axis of the bronchial stentforms a first angle with the longitudinal axis of the first tubulardiagonal arm and the longitudinal axis of the bronchial stent forms asecond angle with the longitudinal axis of the second tubular diagonalarm. In some embodiments, the first angle and the second angle are equalor unequal.

In certain embodiments, the bronchial stent further comprises a thirdtubular arm extending from the stent wherein the third tubular armcomprises a first open end, a second open end, a lumen extendingtherebetween having an inner surface, an outer surface, and alongitudinal axis through the center of the lumen of the third tubulardiagonal arm.

A further aspect of the present invention is directed to a nasal splint.In some embodiments, the nasal splint comprises an oblong-shaped basecomprising a first curved end, a second curved end, and a middle regiontherebetween wherein middle region comprises a first edge, a secondedge, a first surface, a second surface, and a protective coating thatcovers one or more portions of the first surface and/or second surface,of the splint.

In some embodiments, the protective coating may be a polymeric coating.In certain embodiments, the polymer is parylene.

In certain embodiments, the first edge of the middle region may becurved or substantially straight. In some embodiments, the first edge ofthe middle region may further comprise a portion, which resembles theshape of a shark's dorsa fin, extending from the first edge. In furtherembodiments, the second edge of the middle region is curved orsubstantially straight.

In further embodiments, the nasal splint may further comprise tubularstructure on the first surface of the base, wherein the tubularstructure extends between the first end of the base and the second endof the base, and wherein the tubular structure comprises: (i) a firstopen end; (ii) a second open end; (iii) a lumen extending therethroughhaving an inner surface and an inner circumference; (iv) an outersurface; (v) an outer circumference; and (vi) a tubular wall between theinner surface and outer surface.

In certain embodiments, the tubular structure may be adjacent to thefirst edge of the middle region of the base, the second edge of themiddle region of the base, or is in the center of the base. In someembodiments, the first end of the tubular structure and the second endof the tubular structure are curved, and/or the tubular structurebetween the first and the second end is curved.

In some embodiments, nasal splint may further comprise a protectivecoating that covers one or more portions of the inner surface, outersurface, or both the inner surface and outer surface, of the splint. Incertain embodiments, the protective coating is a polymeric coating. Infurther embodiments, the polymer is parylene.

In certain embodiments, nasal stent may further comprise a substantiallyflat segment that extends from the tube and is parallel to the base.

While certain designs of nasal splints are described herein, embodimentsof the present invention are also directed to other nasal splint designsknown in the art, wherein the nasal splints comprise a protectivecoating on one or more portions of the splint surfaces.

The various features of novelty which characterize the invention arepointed out in particularity in the claims annexed to and forming a partof this disclosure. For a better understanding of the invention, itsoperating advantages and specific objects attained by its uses,reference is made to the accompanying descriptive matter in whichpreferred embodiments of the invention are illustrated.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the invention, reference is made tothe following description and accompanying drawings, in which:

FIG. 1 is a side view of a tracheostomy tube according to one aspect ofthe present invention;

FIG. 2 is a cut away view of a tracheostomy tube according to one aspectof the present invention;

FIG. 3 is a front view of a tracheostomy tube according to one aspect ofthe present invention;

FIG. 4 is a front view of a stoma stent according to one aspect of thepresent invention;

FIG. 5 is a cut away view of a stoma stent according to one aspect ofthe present invention;

FIG. 6 is a side view of a stoma stent according to one aspect of thepresent invention;

FIG. 7 is a side view of a T-tube according to one aspect of the presentinvention;

FIG. 8 is a cut away view of a T-tube according to one aspect of thepresent invention;

FIG. 9 is a front view of a T-tube according to one aspect of thepresent invention;

FIG. 10 is a front view of a transtracheal oxygen stent according to oneaspect of the present invention;

FIG. 11 is a top view of a transtracheal oxygen stent according to oneaspect of the present invention;

FIG. 12 is a cut away side view of a transtracheal oxygen stentaccording to one aspect of the present invention;

FIG. 13 is a side view of an oxygen delivery system for thetranstracheal oxygen stent according to one aspect of the presentinvention;

FIG. 14 is a side view of a laryngectomy tube according to one aspect ofthe present invention;

FIG. 15 is a cut away view of a laryngectomy tube according to oneaspect of the present invention;

FIG. 16 is a front view of a laryngectomy tube according to one aspectof the present invention;

FIG. 17 is a side view of a Panje voice button according to one aspectof the present invention;

FIG. 18 is a top view of a Panje voice button according to one aspect ofthe present invention;

FIG. 19 is a cut away view of a Panje voice button according to oneaspect of the present invention;

FIG. 20 is a side view of a Groningen voice button according to oneaspect of the present invention;

FIG. 21 is a cut away view of a Groningen voice button according to oneaspect of the present invention;

FIG. 22 is a top view of a Groningen voice button according to oneaspect of the present invention;

FIG. 23 is a side view of a salivary bypass tube according to one aspectof the present invention;

FIG. 24 is a cut away view of a salivary bypass tube according to oneaspect of the present invention;

FIG. 25 is an end view of a salivary bypass tube according to one aspectof the present invention;

FIG. 26 is a front view of a laryngeal umbrella keel according to oneaspect of the present invention;

FIG. 27 is a side view of a laryngeal umbrella keel according to oneaspect of the present invention;

FIG. 28 is a top view of a laryngeal umbrella keel according to oneaspect of the present invention;

FIG. 29 is a side view of an inner cannula according to one aspect ofthe present invention;

FIG. 30 is a cut-away side view of an inner cannula according to oneaspect of the present invention;

FIG. 31 is a side view of a bronchial stent comprising rings accordingto one aspect of the present invention;

FIG. 32 is a cut-away side view of a bronchial stent comprising ringsaccording to one aspect of the present invention;

FIG. 33 is a side view of a bronchial stent comprising posts accordingto one aspect of the present invention;

FIG. 34 is an end view of a bronchial stent comprising posts accordingto one aspect of the present invention;

FIG. 35 is a cut-away side view of a bronchial stent comprising postsaccording to one aspect of the present invention;

FIG. 36 is a side view of a bronchial Y-tube according to one aspect ofthe present invention;

FIG. 37 is a cut-away side view of a bronchial Y-tube according to oneaspect of the present invention;

FIG. 38 is a side view of a bronchial Y-tube comprising posts accordingto one aspect of the present invention;

FIG. 39 is a cut-away side view of a bronchial Y-tube comprising postsaccording to one aspect of the present invention;

FIG. 40 is a side view of a bronchial TY-tube according to one aspect ofthe present invention;

FIG. 41 is a second side view of a bronchial TY-tube according to oneaspect of the present invention;

FIG. 42 is a cut-away side view of a bronchial TY-tube according to oneaspect of the present invention;

FIG. 43 is a side view of a nasal splint according to one aspect of thepresent invention;

FIG. 44 is a cut-away bottom view of a nasal splint according to oneaspect of the present invention;

FIG. 45 is a side view of a nasal splint comprising a segment extendingfrom the tubular structure of the splint according to one aspect of thepresent invention;

FIG. 46 is an end view of a nasal splint comprising a segment extendingfrom the tubular structure of the splint according to one aspect of thepresent invention;

FIG. 47 is a cut-away bottom view of a nasal splint comprising a segmentextending from the tubular structure of the splint according to oneaspect of the present invention;

FIG. 48 is a side view of a nasal splint comprising a portion thatresembles the shape of a shark's dorsal fin extending from the firstedge according to one aspect of the present invention.

FIG. 49 is an end view of a nasal splint comprising a portion thatresembles the shape of a shark's dorsal fin extending from first edgeaccording to one aspect of the present invention.

FIG. 50 is a second side view of a nasal splint comprising a portionthat resembles the shape of a shark's dorsal fin extending from thefirst edge according to one aspect of the present invention.

FIG. 51 is a second end view of a nasal splint comprising a portion thatresembles the shape of a shark's dorsal fin extending from the firstedge according to one aspect of the present invention.

FIG. 52 is a side view of a Tellez Nasal Splint according to one aspectof the present invention;

FIG. 53 is a cut-away bottom view of a Tellez Nasal Splint according toone aspect of the present invention;

FIG. 54 is a side view of a Doyle Shark Nasal Splint according to oneaspect of the present invention;

FIG, 55 is an end view of a Doyle Shark Nasal Splint according to oneaspect of the present invention;

FIG. 56 is cut-away bottom view of a Doyle Shark Nasal Splint accordingto one aspect of the present invention.

DESCRIPTION OF THE INVENTION

The present invention overcomes the shortcomings of the prior art bycoating airway management devices with a protective polymeric coating.One suitable type of polymer is parylene. Parylene is the name for aseries of polymers based on the monomer, para-xylene (p-xylene), or 1,4dimethyl-benzene. There are three commercially available variations ofparylene that display differences at the monomeric level: parylene N,parylene C, and parylene D. In one preferred embodiment, the instantinvention uses parylene N or parylene C. Parylene is applied in athickness of about 0.00003″ to 0.0001″ and more preferably in athickness of about 0.00005″.

The backbone of the parylene polymer is made entirely of carbon andthereby is not vulnerable to hydrolytic breakdown in an aqueousenvironment. Parylene also has excellent properties as a film lubricantand its coefficient of friction approaches TEFLON®. Also, with adielectric constant relatively independent of frequency and temperature,parylene also is an excellent electric insulator.

The devices contemplated by the present invention can be formed usingany number of materials conventional to those skilled in the art forairway management devices. For example, one preferable material ismedical grade silicone but other materials such as polyvinylchloride(PVC) could also be used without departing from the scope of the presentinvention.

One embodiment of the present invention is a protectively coatedtracheostomy tube as shown in FIGS. 1-3. Areas with a protectivepolymeric coating are illustrated by the shaded regions. FIG. 1 is aside view of a tracheostomy tube 10. The tube 10 is open at the distalend 18 and the proximal end 20. Tube 10 has an outer surface 12 and alumen 16 extending therethrough having an inner surface 14. A neck plate22 is attached at the proximal end 20, which in use rests against apatient's neck. One embodiment of the invention contemplates coatingboth the outer surface 12 of the tube 10 with a protective polymericcoating, as depicted in FIGS. 1 and 3, as well as and the inner surface14 of the lumen 16, as depicted in FIG. 2 Coating the tracheostomy tube10 in this manner serves to control mucus and granulation accumulationboth internally and externally. In addition, such coating serves to easein the insertion and removal of suction tubes. The neck plate 22 ispreferably not coated with the polymeric protective coating.

Those of skill in the art will appreciate that an inner cannula may beinserted to the lumen 16 of the tube 10. FIGS. 29 and 30 depict an innercannula 190 in accordance with an embodiment of the invention. The innercannula 190 may comprise an open distal end 191, an open proximal end192, and a lumen 193 extending therebetween having an inner surface 194,and an outer surface 195. Between the distal end 191 and the proximalend 192, the inner cannula 190 may comprise a general curvature 196which is designed to fit into the tracheostomy tube, e.g., to fitthrough the stoma and into the trachea of the patient. The inner cannula190 may further comprise a sealing ring 197 on the proximal end 191,which prevents mucus from migrating into the area between the outside ofthe inner cannula 190 and the inside of the tracheostomy tube. The innercannula can be made of a softer non-toxic plastic, rubber or siliconematerial.

The outer surface 195 and inner surface 194 (shown in the cut-away viewof the inner cannula 190 in FIG. 30) of the inner cannula may be coatedwith the polymeric protective coating to ease insertion and preventmucus build up or granulation.

FIGS. 4-6 show a stoma stent 24 in accordance with another embodiment ofthe present invention. Surrounding the proximal end 36 of the stomastent 24 is an exterior flange 38 and surrounding the distal end 34 is atracheal flange 40. The exterior flange 38 and the tracheal flange 40are fluidly connected by a tube 26 with an outer surface 28 and with alumen 25 extending therethrough and having an inner surface 30. Theinner surface 30 has a portion 32 proximal to the tracheal flange 40 anda portion 60 proximal to the exterior flange 38.

The exterior flange 38 and the tracheal flange 40 are both coated with aprotective coating. The outer surface 28 is not coated with a protectivecoating in order to prevent the stoma stent 24 from being coughed out ofposition. The inner surface 30 of the lumen 25 is coated with aprotective polymeric material except for the portion 60 proximal to theexterior flange 38. The distal portion 60 is not coated. Coating thetracheal flange 40 with protective material prevents the accumulation ofgranulation, crusting and mucus. Further, the smoother surface reducesthe possibility of compromising the tracheal wall of the patient. Withregard to the exterior flange 38, the protective coating prevents theaccumulation of granulation, crusting and mucus and allows for easiercleaning and maintenance of the stoma stent 24. The uncoated portion 60provides enhanced friction to hold an item such as a cannula or a plug48 firmly in the stoma stent.

As seen in FIGS. 4 and 6, also attached to the exterior flange 38 is atether 46 connected to a plug 48. The plug 48 has a cylindrical innerwall 50 and a tapered outer wall 54 attached axially to a base 52, asshown in FIGS. 4 and 6. The tapered outer wall 54 has a portion 58proximal to the base 52 and a portion 56 distal to the base 52. Thedistal portion 56 is not coated. The plug 48 is of a dimension andconfiguration to fit tightly within the lumen 30 of the tube 26 withbase 52 abutting the exterior flange 38 and the uncoated portion 56 ofthe plug 48 secured to the uncoated portion 60 of the stoma stent 24.

Another embodiment of the invention is a polymer coated tracheal T-tube62, as shown in FIGS. 7-9. FIG. 7 is a side view of a tracheal T-tubewith a vertical arm 64 and a horizontal arm 66 arranged perpendicularlyto the vertical arm 64 in a T shape. Joining the tube arms 64 and 66forms a T-tube 62 having a single lumen 70 and one outer surface 68.Inner surface 72 is located within the vertical arm 64. Inner surface 74is located within the horizontal arm 66. Inner surface 76 also islocated within the horizontal arm 66 at a location distal to thevertical arm 64. The outer surface 68 of the T-tube 62 is coated with aprotective material. Further, the inner surfaces 72 and 74 of thehorizontal and vertical arms 66 and 64 are coated with a protectivelayer which allows for ease of insertion/removal of suction catheter, ifnecessary. However, the inner surface 76 of the horizontal arm 66 is notcoated with a protective coating.

As shown by FIGS. 7 and 9, a tether 78 is attached to the horizontal arm66 and connects a plug 80 to the horizontal arm 66. The plug 80 has acylindrical wall 82 attached axially to a base 83 with a tapered outerwall 84, as shown in FIGS. 7 and 9. The tapered outer wall 84 has aproximal portion 86 and a distal portion 88 to the base 83. The plug 80is of a dimension and configuration to fit tightly adjacent to the innersurface of the distal portion 76 of the horizontal arm 66 of the T-tube62. Correspondingly, the distal portion 88 of the outer wall 84 of plug80 is not coated ensuring a secure fit.

In yet another embodiment, FIGS. 10-12 show a transtracheal oxygen stent90 coated with protective polymer. FIG. 11 shows a top view of atranstracheal oxygen stent 90 having a tube 92 with a lumen 102extending therethrough having an inner surface 100. The tube 92, havingan outer surface 98, is open at the proximal end 94 and the distal end96. A tracheal flange 106 is attached at the distal end 96 of the tube92 and an exterior flange 104 is attached at the proximal end 94, asshown in FIGS. 11 and 12. The tracheal flange 106 and the exteriorflange 104 are both coated with a protective coating. Coating thetracheal flange 106 with protective material prevents the accumulationof granulation, crusting and mucus. Further, the smoother surfacereduces the possibility of compromising the tracheal wall. With regardto the exterior flange 104, the protective coating prevents theaccumulation of granulation, crusting and mucus and allows for easiercleaning and maintenance. What is more, as shown by FIG. 12, the innersurface 100 of the lumen 102 is coated with a protective coating.However, as shown by FIG. 11, the external surface 98 of the tube 92does not have a coating. Coating the inner surface 100 with a protectivematerial will prevent accumulation of crusting and mucus. The externalsurface 98 is not coated with a protective coating to prevent the stent92 from being coughed out of the stoma formed in the patient.

In a further embodiment, the transtracheal oxygen stent 92, as shown inFIGS. 10-12 is adaptable for use with the oxygen delivery catheter 108shown in FIG. 13 and is comprised of tubing 110 that connects the stentshown in FIGS. 19-21 to an oxygen source (not shown). The tubing 110 hasa connecting portion 112 with an outer surface 114 that fits within thelumen 102 of the transtracheal oxygen stent 92, as shown in FIGS. 10-12.The outer surface 114 of the connecting portion 112 has a protectivepolymeric coating to ease insertion.

FIGS. 14-16 show another embodiment of the present invention, namely alaryngectomy tube 116 coated with a protective polymer. The laryngectomytube 116 comprises a curved tube 118 with an outer surface 120. The tube118 has a proximal end 128, a distal end 129 and a lumen 124 whichextends therethrough having an inner surface 122. A neck plate 126 isattached at the proximal end 128 of the tube 118. The neck plate 126,outer surface 120 and inner surface 122 are all coated with theprotective polymer.

Another embodiment of the invention is a protectively coated device forvoice prosthesis. In one embodiment, shown in FIGS. 17-19, a voicebutton 130 has three segments: 134, 136, and 138, and a lumen 142extending therethrough. The voice button 130 has an open tracheal end144 and a valved 152 esophageal end 146. The entire inner surface 140 ofthe lumen 142 is protectively coated to prevent crusting and mucus. Thefirst segment is the tracheal segment 134. The tracheal segment 134includes a tracheal flange 148. The external surface 151 including thesurface of the tracheal flange 148 of the tracheal segment 134 has aprotective coating. Coating the tracheal flange 148 preventsgranulation, crusting and mucus in the device as well as allowing foreasier cleaning and maintenance. The second segment is the intrafistularsegment 136. In use this segment rests in the fistula between thetrachea and the esophagus. The lumen 142 extends between the trachealflange 148 and the esophageal flange 150 and through the intrafistularsegment 136. The external surface 132 of the intrafistular segment 136is not protectively coated. The third segment is the esophageal segment138, including the esophageal flange 150 to the esophageal end 146,which contains a valve system 152 that allows air to pass through thevoice button 130 from the lungs but prevents fluids from the esophagusfrom passing in the opposite direction. The external surface 153 of theesophageal segment 138 is protectively coated. Similarly, the esophagealflange 150 has a protective coating to prevent granulation, crusting,and mucus accumulation. Coating the esophageal flange 150 will alsoprevent the accumulation of food particulates. Another embodiment mayinclude a string 154 attached to the tracheal segment 134 that may beused to retrieve the device from the fistula. This string 154 may alsobe coated with a protective polymeric coating. One skilled in the artwould know the device previously described as a “Panje voice button.”

Another embodiment of the invention is a protectively coated voicebutton 158, as shown in FIGS. 20-22. In this embodiment, the voicebutton 158 has a lumen 160 extending therethrough having an innersurface 161. The voice button 158 has an open tracheal end 168 and anesophageal end 170 with a valve 172. The tracheal end 168 includes atracheal flange 164 and the esophageal end 170 includes an esophagealflange 166. The entire inner surface 161 of the lumen 160 is coated by aprotective coating, however, the external surface 162 of the voicebutton 158 is not coated. The tracheal flange 164 is coated with aprotective coating as is the esophageal flange 166. The valve 172 allowsair to pass through the voice button 158 from the lungs but preventsfluids from the esophagus to pass in the opposite direction. Anotherembodiment includes a string 174 attached to the laryngeal flange 164 toretrieve the device 156 from the fistula. In one embodiment, the string174 is also coated with a protective coating. One skilled in the artwould know the device previously described as a “Groningen voicebutton.”

Yet another embodiment the present invention is a non-respiratory airwaymanagement device such as the salivary bypass tube 176 shown in FIG.23-25. According to the present invention, the salivary bypass tube 176has an exterior surface 182 and a lumen 180 which extends therethrough.The inner surface 178 of the lumen 180 is coated with a protectivepolymeric coating. However, the exterior surface 182 of the tube 176 isnot coated with a protective polymeric coating. In one embodiment of theinvention, the tube 176, having proximal 175 and distal 177 ends,further comprises a funnel 179 attached to the proximal end 175. Theinner surface 181 of the funnel 179 has a protective polymeric coatingbut the outer surface 183 of the funnel 179 is not so coated.

A further embodiment of the present invention is a non-respiratoryairway management device such as the laryngeal umbrella keel 184 shownin FIGS. 26-28. The laryngeal umbrella keel 184 is comprised of anumbrella-like extralaryngeal cover 186 and a thin intralaryngeal insert188, joined perpendicularly in a T-shape. The umbrella-likeextralaryngeal cover 186 is not coated with a protective polymer. Thethin intralaryngeal insert 188 is protectively coated. Coating the thinintralaryngeal cover 188 prevents the formation of granulation and easesremoval of the device, thereby reducing the possibilities of vocal chordadhesions.

Yet another embodiment of the present invention relates to a bronchialstent system, such as the bronchial stent shown in FIGS. 31-35. Areaswith a protective polymeric coating are illustrated by the shadedregions. The stent 200 may be tubular in shape, and comprise an opendistal end 201 and an open proximal end 202. The stent may also comprisea lumen 203 extending between the distal end 201 and the proximal end202, such that the lumen 203 comprises an inner surface 204, an outersurface 205, and a longitudinal axis 206 through the center of thelumen. The lumen 203 and the inner surface 204 are shown in the cut awayside view of the bronchial stent in FIG. 32.

The bronchial stent 200 may further comprise a means to prevent movementor displacement of the stent during use. Means to prevent movement ordisplacement may comprise one or more rings around the circumference ofthe stent, one or more posts or protrusions that extend from the outersurface of the stent, or the like. For example, the embodiment depictedin FIGS. 31 and 32 demonstrate a bronchial stent 200 comprising rings207 as a means to prevent movement or displacement of the stent. Therings 207 may be located at the distal end 201, the proximal end 202,any site therebetween, or any combination thereof. In the embodimentshown in FIGS. 31 and 32, the rings 207 are located at the distal end201 and proximal end 202.

Another example of means to prevent displacement or movement of thebronchial stent 200 may be posts, or protrusions, which extend radiallyfrom the surface of the stent. For instance, FIGS. 33-35 depict abronchial stent 200 comprising posts 208 shown in a side view (FIG. 33),in a cross-sectional view (FIG. 34), and in a cut-away side view (FIG.35). The posts 208 can be of any shape or form, including cubic posts,cylindrical posts, pyramidal posts, and other prism-shaped posts. Theposts may be. distributed evenly or unevenly around the circumference ofthe bronchial stent, and there may be one or more rows of posts. In theembodiments depicted in FIGS. 33-35, the posts are in four rowsdistributed evenly around the circumference of the bronchial stent.

The bronchial stent may additionally comprise a coating on one or moreportions of the inner surface 204, the outer surface 205, or both theinner surface 204 and outer surface 205. Coating the bronchial tube 200in this manner serves to control mucus and granulation accumulation bothinternally and externally, as well as prevent adhesion to tissues whichcan cause bleeding upon removal, and prevent build-up of blood, or bloodclots, to the stent. In certain embodiments, the entire inner surface204 or outer surface 205, or both, may be coated.

The bronchial stent may further comprise a bifurcation on the distal endof the bronchial stent to form a bronchial Y-tube 210, as shown in FIGS.36-39. The distal end may bifurcate into a first tubular diagonal arm211 and a second tubular diagonal arm 221. The first tubular diagonalarm 211 may comprise an open distal end 212 and an open proximal end213. The first tubular diagonal arm 211 may also comprise a lumen 214extending between the distal end 212 and the proximal end 213 and havingan inner surface 215, an outer surface 216, and a longitudinal axis 217through the center of the lumen 214. The second tubular diagonal arm 221may comprise an open distal end 222 and an open proximal end 223. Thesecond first tubular diagonal arm 221 may also comprise a lumen 224extending between the distal end 222 and the proximal end 223 and havingan inner surface 225, an outer surface 226, and a longitudinal axis 227through the center of the lumen 224. The lumen 214 in the first diagonalarm 211 and the lumen 224 in the second diagonal arm 221 may becontinuous with the lumen 203 of the stent 200.

The lengths of the first diagonal arm 211 and the second diagonal arm221 may be equal or unequal. Referring to the location of the diagonalarms around the circumference of the stent, the first tubular diagonalarm 211 and the second tubular diagonal arm 221 may be 180° apart aroundthe circumference. In some embodiments, the first tubular diagonal arm211 and the second tubular diagonal arm 221 may be between 0° and 180°,or between 45° and 135° or about 90° apart around the circumference.

The longitudinal axis 206 of the bronchial stent 200 may form a firstangle 218 with the longitudinal axis 217 of the first tubular diagonalarm. The longitudinal axis 206 of the stent 200 may form a second angle228 with the longitudinal axis 227 of the second tubular diagonal arm221. The first angle 218 and the second angle 219 may be between 0° and90°, or between 15° and 75° or between 30° and 60°. The first angle 218may be the equal or unequal to the second angle 228.

The bronchial Y-tube may also comprise a coating on one or more portionsof the inner surface, outer surface, or both, as described above.

The bronchial Y-tube may further comprise means for preventingdisplacement or movement as described above. For example, FIGS. 38 and39 depict the bronchial Y-tube having posts 229 as a means forpreventing movement or displacement.

The bronchial stent 200 or the bronchial y-tube 210 may further compriseone or more tubular arms extending from the stent. FIGS. 40-43 depict anembodiment wherein a bronchial Y-tube comprises a third tubular arm 231extending to form a bronchial TY-tube 230. The third tubular arm 231 maycomprise a first open end 232 and a second open end 233. The thirdtubular arm 231 may also comprise a lumen 234 extending between thefirst open end 232 and the second open end 233 and having an innersurface 235, an outer surface 236, and a longitudinal axis 237 throughthe center of the lumen 234. The lumen 234 in the third tubular arm 231may be continuous with the lumen 203 of the stent 200.

The longitudinal axis 206 of the bronchial stent 200 may form a thirdangle 238 with the longitudinal axis 237 of the third arm. The angle 238may be between 0° and 180°, or between 45° and 135° or about 90°.

Referring to the location of the third tubular arm 231 around thecircumference of the stent, the third tubular arm 231 may be alignedwith either of the tubular diagonal arms 211 or 221, or may be unalignedwith either tubular diagonal arm 211 or 221 and may be between 0° and180° apart around the circumference from either tubular diagonal arm 211or 221. If there is more than one tubular arm extending from thebronchial stent, these additional arms may aligned or unaligned with thetubular diagonal arms 211 and 221. Further, these addition arms may atthe same site along the length of the bronchial stent or they may be atdifferent sites.

The bronchial TY-tube may also comprise a coating on one or moreportions of the inner surface, outer surface, or both, as describedabove.

The bronchial TY-tube may further comprise means for preventingdisplacement or movement, such as rings or posts or the like, asdescribed above.

In the bronchial stent embodiments of the present invention, includingthe bronchial tubes, e.g., bronchial Y-tube, bronchial TY-tube, etc.,the open distal and open proximal ends of the tube may be featheredoutwardly or inwardly to facilitate its use within the airways.

Therefore, FIGS. 31-42 depict various embodiments of bronchial stent,bronchial Y-tube, and bronchial TY-tube. For example, FIGS. 31 and 32show a bronchial stent 200 comprising a protective coating on its outersurface 205 and inner surface 204, and rings 207 on the distal end 201and proximal end 202 as a means to prevent movement or displacement ofthe stent 200.

FIGS. 33 and 35 show a bronchial stent 200 comprising a protectivecoating on its outer surface 205 and inner surface 204, and posts 208along the outer surface 205 of the stent 200.

FIGS. 36 and 37 show a bronchial Y-tube 210 comprising a bronchial stent200 having a bifurcation, which comprises a first tubular diagonal arm211 and a second tubular diagonal arm 221 which extends distally. Thebronchial Y-tube also comprises a protective coating on the outersurfaces 205, 216 and 226, and inner surfaces 204, 215 and 225.

FIGS. 38 and 39 show a bronchial Y-tube 210 comprising a bronchial stent200 having a bifurcation, which comprises a first tubular diagonal arm211 and a second tubular diagonal arm 221 which extends distally. Thebronchial y-tube also comprises a protective coating on the outersurfaces 205, 216 and 226 and inner surfaces 204, 215 and 225, and posts229 along the outer surfaces 216 and 226.

FIGS. 40-42 show a bronchial TY-tube 230 comprising a bronchial stent200 having a bifurcation comprising a first tubular diagonal arm 211 anda second tubular diagonal arm 221 which extends distally from the distalend of the stent 200, and a third tubular arm 231 extending from thestent 200. The bronchial TY-tube also comprises a protective coating onthe outer surfaces 205, 216, 226, and 236, inner surfaces 204, 215, 225,and 235.

Another embodiment of the present invention relates to a nasal splint260, such as the nasal splints shown in FIGS. 43-54, which representdifferent embodiments. The nasal splint 260 may comprise a base 261comprising a first curved end 262, a second curved end 263, a middleregion 264 extending therebetween, a first surface 265, and a secondsurface 266, such that the middle region comprises a first edge 267 anda second edge 268. The base 261 may be oblong in shape. The first edge267 and the second edge 268 of the middle region 264 may be curved orsubstantially straight. The first edge 267 of the middle region 264 mayalternatively comprise a portion that resembles the shape of a shark'sdorsal fin, as depicted in FIGS. 48, 50, and 54.

The nasal splint 260 may further comprise a hole 269 near the firstcurved end 262, near the second curved end 263, or a combinationthereof. The holes 269 are for purposes of suturing. The edge of thehole may be level with first surface 265 and/or the second surface 266,or the edge of the hole may comprise a lip. Also, the base 261 at thesite of the holes may have a greater cross-section than other sites ofthe base 261. The holes 269 provide a secure feature that will allow thephysician to pass a suture through, without tearing the silicone device.The suture aids in holding the splint in position.

The base 261 may be substantially flat and in the same plane, a depictedin FIGS. 44, 46, 47, and 53. Alternatively, a portion of the base 261may be in a different plane. For example, FIGS. 49, 51, and 56 show aportion of the base 261 that is in a different plane; in FIGS. 49 and51, this portion corresponds to the portion that resembles the shape ofa shark's dorsal fm depicted in FIGS. 48 and 50.

The nasal splint 260 may also comprise a polymer coating on one or moreor all of the surfaces of the nasal splint 260. Coating the nasal splint260 in this manner serves to allow for ease of removal and to eliminatethe possibility of bleeding. The coated splint does not adhere to anytissue, and prevents accumulation of adhesions, granulations, crusting,and mucus/blood. In addition, the coating will prevent adhesion totissues which can cause bleeding upon removal, and prevent build-up ofblood, or blood clots, to the device.

The nasal splint 260 may further comprise a tubular structure 270 on thefirst surface 265, as shown in FIGS. 43-47 and 52-55. The tubularstructure 270 may extend between the first curved end 262 and the secondcurved end 263 of the base 261. The tubular structure 270 may comprisean open first end 271 and an open second end 272. The tubular structuremay also comprise a lumen 273 extending between the first open end 271and the second open end 272 such that the lumen 273 comprises an innersurface 274, and an outer surface 275.

The tubular structure 270 may be of any length, but is limited by thedistance between the first curved end 262 and second curved end 263 ofthe base 261. The tubular structure may also be located at any sitebetween the first edge 267 and the second edge 268 of the base 261. Forexample, the tubular structure 270 may be adjacent to the first edge 267as depicted in FIG. 43, or may be adjacent to the second edge 268, oranywhere between as depicted in FIGS. 45 and 54. The tubular structure270 may be of a particular size such that it is simultaneously adjacentto both the first edge 267 and the second edge 268 of the base 261, asshown in FIG. 52.

The open first end 271 and the open second end 272 may be curved, forexample, as shown in FIG. 43 or 52. The open first end 271 and the opensecond end 272 may also be angled, for instance, as shown in FIG. 44 or53.

The tubular structure 270 between first open end 271 and the second openend 272 may comprise a curvature 276. The curvature 276 may be the sameas the curvature of the first edge 267.

The tubular structure may additionally comprise a coating on one or moreportions of the inner surface 274, the outer surface 275, or both theinner surface 274 and outer surface 275. Coating the tubular structure270 in this manner serves to control mucus and granulation accumulationboth internally and externally, as well as prevent adhesion to tissueswhich can cause bleeding upon removal, and prevent build-up of blood, orblood clots, to the stent. In certain embodiments, the entire innersurface 274 or outer surface 275, or both, may be coated.

The tubular structure may comprise a substantially flat segment 277which extends from the tubular structure. The segment 277 may extendtowards either the first edge 267 or the second edge 268 of the base261. The segment 277 may be parallel with the base 261.

Yet another embodiment relates to the Tellez Nasal Splint or the DoyleShark Nasal Splint comprising protective coating as described above (seeFIGS. 52-55).

Thus, FIGS. 43-56 depict various embodiments of the nasal splints. Forexample, FIGS. 43 and 44 show a nasal splint 260 comprising a protectivecoating on its base surfaces 265 and 266, and a tubular structure 270which comprises a protective coating on its outer surface 275 and innersurface 274. Also, the first open end 271 and the second open end 272 ofthe tubular structure 270 is curved, and the tubular structure comprisesa curvature that is the same as the curvature of the first edge 267 ofthe splint.

FIGS. 45-47 show a nasal splint 260 comprising a protective coating onits surfaces 265 and 266, and a tubular structure 270 which comprises aprotective coating on its outer surface 275 and inner surface 274. Also,the first open end 271 and the second open end 272 of the tubularstructure 270 is not curved, and the tubular structure between the firstopen end 271 and the second open end 272 is substantially straight.Further, the tubular structure 270 comprises a substantially flatsegment 277 which extends from the tubular structure and is parallel tothe 261 of the splint 260.

FIGS. 45-47 show a nasal splint 260 comprising a protective coating onits surfaces 265 and 266, and a tubular structure 270 which comprises aprotective coating on its outer surface 275 and inner surface 274. Also,the first open end 271 and the second open end 272 of the tubularstructure 270 is not curved, and the tubular structure between the firstopen end 271 and the second open end 272 is substantially straight.Further, the tubular structure 270 comprises a substantially flatsegment 277 which extends from the tubular structure and is parallel tothe 261 of the splint 260.

FIGS. 48-51 show a nasal splint 260 comprising a protective coating onits surfaces 265 and 266, and comprising a first edge 267 of the middleregion 264 which comprises a portion that resembles the shape of ashark's dorsal fin. Further, the portion of the base 261 comprising aportion that resembles the shape of a shark's dorsal fin is not in thesame plane as the rest of the base.

FIGS. 52 and 53 show the Tellez Nasal Splint comprising a protectivecoating on its surfaces 265 and 266.

Finally, FIGS. 54-56 show the Doyle Shark Nasal Splint comprising aprotective coating on its surfaces 265 and 266.

While specific embodiments of the subject invention have been discussed,the above specification is illustrative and not restrictive. One skilledin the art will appreciate that numerous changes and modifications canbe made to the invention, and that such changes and modifications can bemade without departing from the spirit and scope of the invention. Thefull scope of the invention should be determined by reference to theclaims, along with their full scope of equivalents, and thespecification, along with such variations.

What is claimed is:
 1. A bronchial stent having a generally tubularshape comprising: (a) an open distal end, an open proximal end, a lumenextending therebetween having an inner surface, an outer surface, and alongitudinal axis through the center of the lumen; (b) a means toprevent movement or displacement of the stent; and (c) a protectivecoating that covers one or more portions of the outer surface, innersurface, or both the outer and inner surface, of the stent.
 2. Thebronchial stent of claim 1, wherein the means to prevent movement ordisplacement of the stent is one or more rings around the circumferenceof the stent, one or more posts that extend outwardly from the outersurface of the stent, or a combination thereof.
 3. The bronchial stentof claim 2, wherein the one or more rings are located on the distal endof the stent, the proximal end of the stent, between the distal end andproximal end of the stent, or any combination thereof.
 4. The bronchialstent of claim 2, wherein the posts are cylindrical, cubic, pyramidal,or prism-shaped.
 5. The bronchial stent of claim 2, wherein the postsare distributed randomly or in a pattern along the outer surface of thestent.
 6. The bronchial stent of claim 1, wherein the protective coatingis a polymeric coating.
 7. The bronchial stent of claim 6, wherein thepolymer is parylene.
 8. The bronchial stent of claim 1, wherein thedistal end of the bronchial stent bifurcates into a first tubulardiagonal arm and a second tubular diagonal arm, wherein each armcomprises an open distal end, an open proximal end, a lumen extendingtherebetween having an inner surface, an outer surface, and alongitudinal axis through the center of the lumen of each diagonal arm.9. The bronchial stent of claim 8, wherein the lumen in the diagonalarms is continuous with the lumen of the stent.
 10. The bronchial stentof claim 8, wherein the lengths of the first diagonal arm and the seconddiagonal arm are equal.
 11. The bronchial stent of claim 8, wherein thelengths of the first diagonal arm and the second diagonal arm areunequal.
 12. The bronchial stent of claim 8, wherein the longitudinalaxis of the bronchial stent forms a first angle with the longitudinalaxis of the first diagonal arm and wherein the longitudinal axis of thebronchial stent forms a second angle with the longitudinal axis of thesecond diagonal arm.
 13. The bronchial stent of claim 12, wherein thefirst angle and the second angle are equal.
 14. The bronchial stent ofclaim 12, wherein the first angle and the second angle are unequal. 15.The bronchial stent of claim 1, wherein the bronchial stent furthercomprises a third tubular arm extending from the stent wherein the thirdtubular arm comprises a first open end, a second open end, and a lumenextending therebetween having an inner surface, an outer surface, and alongitudinal axis through the center of the lumen of the third tubulararm.